Heart disease is the leading cause of death in the United States, accounting for more deaths than all forms of cancer combined. Heart failure—the most common, costly, disabling and deadly of heart ailments—affects close to five million people in the United States, and each year about 550,000 new cases are diagnosed. The mortality rate is approximately 40,000 a year, but heart failure is listed as a contributing cause of 280,000 deaths every year. It is also the leading cause for hospitalization in people older than 65. Of more concern is the fact that more than 50% of patients seek re-admission within six months after treatment, and the average duration of hospital stays is six days. Its health care cost in the United States. is estimated to be more than $35 billion.
Heart failure can be treated medically. However, many patients in advanced stages of heart failure do not respond to medications. Heart transplantation is the ultimate remedy. About 60,000 end-stage heart failure patients may benefit from heart transplantation, but only 2,100 receive heart transplants annually because of limited availability of organs. Totally artificial hearts could save more patients from donor heart shortage.
Medical devices have been used safely and effectively to assist the failing heart and the circulation. There are many assist devices already available, including ventricular assist devices (VAD) and totally artificial hearts (TAH). VAD's continue to play a role as temporary circulatory support, bridge-to-heart transplantation or, for some devices, destination therapy (traveling to a remote location for medical services).
There are various forms of VADs. They are classified as to how a VAD is used (LVAD, RVAD or BiVAD); where a VAD is located (extracorporeal or implantable); or how its pump works (pulsatile or continuous flow). Although FDA-approved for clinical uses, presently available designs are still prone to serious complications, such as infection, bleeding and stroke. Cables being inserted through the skin become sources of infection because batteries and controls worn outside the body drive these devices. Heparin anticoagulation is a requirement for most of these devices. Excessive anticoagulation causes bleeding, while inadequate anticoagulation can lead to strokes.
(5) This invention is a self-contained and totally implantable blood pump that replaces the whole heart. This mechanical heart and the controls, including the power source, are self-contained and totally implanted inside the body. There are no external cables or connections. The hemodynamic benefit is achieved and controlled by the built-in microcontroller that makes the heart autonomously adjust to blood pressure, physical activity and/or body posture.